Ozone therapy to boost remineralization of early caries in kids
Official title: Effect of Ozone Therapy on the Remineralization of Initial Caries Lesions in Children: A Randomized Controlled Clinical Trial
Run by Marmara University · NCT07671651 · Data updated 2026-11-12
This study tests whether adding ozone therapy to a remineralizing gel helps children aged 6–12 remineralize early, non-cavitated caries lesions better than the gel alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 14 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul, Maltepe) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | April 20, 2027 |
| Study ends | April 20, 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07671651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–12 with at least one initial non-cavitated caries lesion, who are systemically healthy and can comply with follow-up.
✕Probably not a fit
Children with cavitated lesions, systemic diseases affecting oral health, or those unable to attend follow-ups may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares two approaches for managing initial non-cavitated caries in children: ozone therapy followed by a remineralizing gel versus the remineralizing gel alone. Participants will be assigned to groups and followed over time with clinical and optical assessments to track changes in lesion status. The aim is to see if ozone can provide an extra benefit in promoting remineralization and preventing lesion progression. The study targets pediatric patients who are otherwise healthy and able to attend follow-up visits. Results could support minimally invasive management of early caries.
Why it matters
Potential benefit: If successful, the approach could enhance remineralization of early caries and reduce the need for drilling.
How similar studies have gone: Prior evidence on ozone’s added benefit to remineralization is limited, making this investigation relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria Children aged 6-12 years. Presence of at least one initial non-cavitated caries lesion. Systemically healthy children. Frankl Behavior Rating Scale score of 3 or 4. Written informed consent obtained from the parent or legal guardian. Exclusion Criteria Cavitated caries lesions requiring restorative treatment. History of allergy to any study material. Systemic diseases affecting oral health or salivary flow. Respiratory diseases (e.g., asthma) contraindicating ozone therapy. Use of medications affecting salivary flow or enamel remineralization. Uncooperative children (Frankl score 1 or 2). Parent or guardian unwilling to participate or unable to attend follow-up visits.
Where it's running
-
Marmara Universty School of Dentistry
Istanbul, Maltepe, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Neslihan Atmaca, Doctor of Dental Surgery
- Email: nsltmc@gmail.com
- Phone: +905458314053
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.